OpenOnco · Treatment Plan

Treatment plan — Invasive breast cancer

PLAN-BREAST-TNBC-2L-SACI-001-V1 · v1 · 2026-08-18

Patient

BREAST-TNBC-2L-SACI-001 · Algorithm: ALGO-BREAST-TNBC-2L

DiagnosisInvasive breast cancer

MOH / ICD-10C50

ICD-O-38500/3; C50.9

StageIV

Histologyinvasive_ductal_carcinoma_NST

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks

✅ Covered biomarkers (matched in KB)

Biomarker	Variant	ESCAT	Evidence	Clinical significance	Drugs	Sources
No clinically actionable variants matched in this profile.

⚠️ Not included in plan

Biomarker	Status
BIO-ER	Excluded (negative)
BIO-PR	Excluded (negative)
BIO-HER2-SOLID	Excluded (negative)
BIO-PDL1-CPS	BIO definition in KB; no ESCAT BMA entry — verify with clinician

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-BREAST-TNBC-2L-SACITUZUMAB

Regimen

Sacituzumab govitecan monotherapy (TNBC ≥2L; HR+/HER2- ≥3L)

Drugs + NSZU

Sacituzumab govitecan (DRUG-SACITUZUMAB-GOVITECAN) 10 mg/kg IV · Days 1, 8 of 21-day cycle, until progression · IV ✗ Not registered in UA

Supportive care

SUP-G-CSF-PRIMARY-PROPHYLAXIS-PROSTATE, SUP-BONE-HEALTH-PROSTATE

Reason

Primary current-line option selected by ALGO-BREAST-TNBC-2L at step 4.

Other current-line alternatives (3 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.

Standard plan

Indication

IND-BREAST-TNBC-2L-BRCA-OLAPARIB

Regimen

Olaparib monotherapy (BRCA-mutant HER2- breast: metastatic OR adjuvant high-risk early)

Drugs + NSZU

Olaparib (DRUG-OLAPARIB) 300 mg PO BID continuous · Until progression (metastatic) or 1 year (OlympiA adjuvant) · PO ⚠ NSZU — not for this indication

Supportive care

SUP-BONE-HEALTH-PROSTATE

Reason

Current-line alternative presented for HCP consideration

Standard plan

Indication

IND-BREAST-TNBC-2L-BRCA-TALAZOPARIB

Regimen

Olaparib monotherapy (BRCA-mutant HER2- breast: metastatic OR adjuvant high-risk early)

Drugs + NSZU

Olaparib (DRUG-OLAPARIB) 300 mg PO BID continuous · Until progression (metastatic) or 1 year (OlympiA adjuvant) · PO ⚠ NSZU — not for this indication

Supportive care

SUP-BONE-HEALTH-PROSTATE

Reason

Current-line alternative presented for HCP consideration

Standard plan

Indication

IND-BREAST-TNBC-2L-T-DXD-HER2-LOW

Regimen

T-DXd monotherapy (HER2+ metastatic 2L+, also HER2-low metastatic)

Drugs + NSZU

Trastuzumab deruxtecan (T-DXd) (DRUG-TRASTUZUMAB-DERUXTECAN) 5.4 mg/kg IV · Day 1 of 21-day cycle, continuous until progression · IV ✓ NSZU covered

Supportive care

SUP-BONE-HEALTH-PROSTATE

Reason

Current-line alternative presented for HCP consideration

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks

ID	Name	Priority	Category	Where to order	Needed for
TEST-CECT-CAP	CECT chest/abdomen/pelvis	Critical	imaging	—	all tracks
TEST-ER-PR-IHC	ER + PR immunohistochemistry on tumor	Critical	—	CSD Lab ✓ (code TBC)	all tracks
TEST-HER2-IHC-FISH	HER2 IHC + reflex FISH on tumor	Critical	—	CSD Lab ✓ (code TBC)	all tracks
TEST-GERMLINE-BRCA-PANEL	Germline BRCA1/2 + HRR panel sequencing	Standard	—	CSD Lab: M089	all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

HER2-ultralow breast cancer (IHC > 0 < 1+; faint/incomplete membrane staining ≤10% of tumor cells) — a sub-tier between IHC 0 and IHC 1+ not part of standard ASCO/CAP scoring. DESTINY-Breast06 (Bardia 2024 ASCO plenary) extended T-DXd benefit beyond HER2-low to HER2-ultralow HR+ metastatic breast post-endocrine + CDK4/6i, chemo-naive in the metastatic setting (HER2-low cohort mPFS 13.2 vs 8.1 mo, HR 0.62; HER2-ultralow exploratory n=153 mPFS 13.2 vs 8.3 mo, HR 0.78). FDA label expansion anticipated 2026 — candidate RF until pivotal-trial Source SRC-DESTINY-BREAST06-BARDIA-2024 ingested.
Candidate RF — DESTINY-Breast06 trial-Source not yet ingested (SRC-DESTINY-BREAST06-BARDIA-2024 flagged in BIO-HER2-ULTRALOW notes). Pathology re-scoring required: ASCO/CAP 2018 / 2023 guideline does not formally distinguish ultralow from…
RF-BREAST-HER2-ULTRALOW-CANDIDATESRC-NCCN-BREAST-2025SRC-ESMO-BREAST-METASTATIC-2024
HBV/HCV/HIV serology + dental evaluation pre-bisphosphonate/denosumab + DPYD genotyping for capecitabine-containing regimens (EU practice).
Cross-disease HBV reactivation handled by RF-UNIVERSAL-HBV-REACTIVATION- RISK. DPYD deficiency screening unique to fluoropyrimidine-containing regimens; severe / fatal toxicity in homozygous deficient patients — EU/EMA-recommended pre-test.
RF-BREAST-INFECTION-SCREENINGSRC-NCCN-BREAST-2025SRC-ESMO-BREAST-EARLY-2024

CONTRA-AGGRESSIVE

Hard contraindications to escalation

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Sacituzumab govitecan monotherapy (TNBC ≥2L; HR+/HER2- ≥3L)

21-day cycles × Continuous until progression

Standard plan

Induction · Olaparib monotherapy (BRCA-mutant HER2- breast: metastatic OR adjuvant high-risk early)

28-day cycles × Adjuvant: 12; Metastatic: continuous until progression

Standard plan

Induction · T-DXd monotherapy (HER2+ metastatic 2L+, also HER2-low metastatic)

21-day cycles × Continuous until progression or unacceptable toxicity

MDT brief

Discussion questions (1, 0 blocking)

OQ-BIOMARKER-BRCA1-BRCA2-GERMLINE
What is the status of BRCA1/BRCA2 germline pathogenic variant (BIO-BRCA1-BRCA2-GERMLINE)? It is required by track(s): IND-BREAST-TNBC-2L-BRCA-OLAPARIB, IND-BREAST-TNBC-2L-BRCA-TALAZOPARIB. Expected value: pathogenic OR likely-pathogenic germline variant.
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ molecular_geneticist

MDT talk tree (1 steps)

#	Owner	Topic	Action
1	molecular_geneticist	Biomarker status	What is the status of BRCA1/BRCA2 germline pathogenic variant (BIO-BRCA1-BRCA2-GERMLINE)? It is required by track(s): IND-BREAST-TNBC-2L-BRCA-OLAPARIB, IND-BREAST-TNBC-2L-BRCA-TALAZOPARIB. Expected value: pathogenic OR likely-pathogenic germline variant.

Skills (recommended) — for consideration (1)

Molecular geneticist / molecular oncologist recommended
Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.
Owns: OQ-BIOMARKER-BRCA1-BRCA2-GERMLINE

Data quality

Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.

Biomarker coverage: 1/2 known (50%), 1 missing, 0 default-track gaps
Unevaluated RedFlags: RF-ACTIVE-AUTOIMMUNE-DISEASE-ICI-RISK, RF-ATM-CONFIRMED-CARRIER, RF-ATM-FAMILY-HISTORY-SUSPICION, RF-BARD1-CONFIRMED-CARRIER, RF-BARD1-FAMILY-HISTORY-SUSPICION, RF-BLM-CONFIRMED-CARRIER, RF-BRCA-CONFIRMED-CARRIER, RF-BRCA-HBOC-FAMILY-HISTORY-SUSPICION, RF-BREAST-AKT1-E17K-ACTIONABLE, RF-BREAST-AKT1-E17K-CAPIVASERTIB-CANDIDATE, RF-BREAST-BRCA-GERMLINE-ACTIONABLE, RF-BREAST-CDH1-LOBULAR-CANDIDATE, RF-BREAST-EARLY-STAGE, RF-BREAST-ESR1-MUT-ACTIONABLE, RF-BREAST-ESR1-Y537S-D538G-CANDIDATE, RF-BREAST-FRAILTY-AGE, RF-BREAST-HER2-AMP-ACTIONABLE, RF-BREAST-HER2-LOW-ACTIONABLE, RF-BREAST-HER2-ULTRALOW-CANDIDATE, RF-BREAST-HIGH-RISK-BIOLOGY, RF-BREAST-INFECTION-SCREENING, RF-BREAST-ORGAN-DYSFUNCTION, RF-BREAST-OVARIAN-HRD-ASSAY-DISTINCTION, RF-BREAST-PIK3CA-COALT-INAVOLISIB-CANDIDATE, RF-BREAST-PIK3CA-MUT-ACTIONABLE, RF-BREAST-STAGE-IV-METASTATIC, RF-BREAST-TNBC, RF-BREAST-TRANSFORMATION-PROGRESSION, RF-CASCADE-BRCA-FDR-POSITIVE, RF-CASCADE-LFS-FDR-POSITIVE, RF-CHEK2-CONFIRMED-CARRIER, RF-CHEK2-FAMILY-HISTORY-SUSPICION, RF-CHRONIC-SEVERE-OBESITY-BMI40-PREVENTION, RF-CHRONIC-T2DM-CANCER-RISK-PREVENTION, RF-COWDEN-CONFIRMED-CARRIER, RF-COWDEN-FAMILY-HISTORY-SUSPICION, RF-HDGC-CDH1-CONFIRMED-CARRIER, RF-IATROGENIC-COMBINED-HRT-PREVENTION, RF-IATROGENIC-IODINE131-SECONDARY-PREVENTION, RF-IATROGENIC-LONG-TERM-HRMNL-CONTRACEPTION-PREVENTION, RF-IATROGENIC-PRIOR-RADIATION-PREVENTION, RF-LI-FRAUMENI-CONFIRMED-CARRIER, RF-LI-FRAUMENI-FAMILY-HISTORY-SUSPICION, RF-LIFESTYLE-ALCOHOL-CANCER-PREVENTION, RF-LIFESTYLE-OBESITY-CANCER-PREVENTION, RF-LIFESTYLE-SEDENTARY-PREVENTION, RF-LIFESTYLE-SUGARY-BEVERAGES-PREVENTION, RF-NBN-CONFIRMED-CARRIER, RF-NF1-CONFIRMED-CARRIER, RF-NF1-FAMILY-HISTORY-SUSPICION, RF-OCC-IONIZING-RADIATION-PREVENTION, RF-OCC-SHIFTWORK-CIRCADIAN-PREVENTION, RF-PALB2-CONFIRMED-CARRIER, RF-PALB2-FAMILY-HISTORY-SUSPICION, RF-PAN-ATM-CHEK2-CDK12-PARPI-CANDIDATE, RF-PAN-BRCA-SOMATIC-PARPI-CANDIDATE, RF-PAN-PALB2-PARPI-CANDIDATE, RF-PEUTZ-JEGHERS-CONFIRMED-CARRIER, RF-PEUTZ-JEGHERS-FAMILY-HISTORY-SUSPICION, RF-RAD51C-D-CONFIRMED-CARRIER, RF-RAD51C-D-FAMILY-HISTORY-SUSPICION, RF-REPRODUCTIVE-BREAST-ENDOMETRIAL-PREVENTION, RF-REPRODUCTIVE-DES-IN-UTERO-EXPOSURE-PREVENTION, RF-REPRODUCTIVE-LATE-FIRST-PREGNANCY-PREVENTION, RF-REPRODUCTIVE-OCP-LONG-TERM

Missing biomarker	Label	MDT owner	Default track	Required by	Next action
`BIO-BRCA1-BRCA2-GERMLINE`	BRCA1/BRCA2 germline pathogenic variant	molecular_geneticist	no	IND-BREAST-TNBC-2L-BRCA-OLAPARIB, IND-BREAST-TNBC-2L-BRCA-TALAZOPARIB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: pathogenic OR likely-pathogenic germline variant

Technical MDT skill metadata (1/16 activated in this plan)

All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).

Specialist	skill_id	Version	Last reviewed	Domain
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	cellular_therapy

Sources cited

SRC-ASCENT-BARDIA-2021: Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer (2021)
SRC-DESTINY-BREAST04-MODI-2022: Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer (2022)
SRC-EMBRACA-LITTON-2018: Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation (2018)
SRC-ESMO-BREAST-METASTATIC-2024: ESMO Clinical Practice Guideline on Metastatic Breast Cancer (2024)
SRC-NCCN-BREAST-2025: NCCN Clinical Practice Guidelines — Breast Cancer (2025.v4)
SRC-OLYMPIAD-ROBSON-2017: Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation (2017)

Experimental options (clinical trials)

Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-08-18.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06790264	Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer	NA	RECRUITING	European Institute of Oncology	—	Single country
NCT06716073	Long-Term Outcomes of Endoscopic-assisted vs Conventional Breast-conserving Surgery in Breast Cancer Patients After Neoadjuvant Therapy: a Randomized, Multicenter, Open Label, Non-inferiority Trial	NA	RECRUITING	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	—	Surrogate endpoint only Single country
NCT05861271	Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer	PHASE2	RECRUITING	Fudan University	—	Surrogate endpoint only Single country
NCT06807502	Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device	NA	RECRUITING	ScreenCell	—	Single country
NCT04790305	Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer	PHASE4	RECRUITING	Fudan University	—	Surrogate endpoint only Single country
NCT07003009	Immun Checkpoint Washout in Patients With Invasive Ductal Breast Cancer	NA	RECRUITING	Istanbul Training and Research Hospital	—	Small N (<50) Single country
NCT06823414	Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy	N/A	RECRUITING	Alejandra García-Novoa	—	Single country
NCT03201861	Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women	PHASE3	RECRUITING	RenJi Hospital	—	Surrogate endpoint only Single country
NCT07260188	Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy	N/A	RECRUITING	Istituti Clinici Scientifici Maugeri SpA	—	Single country
NCT02945579	Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy	NA	RECRUITING	M.D. Anderson Cancer Center	—	Single country

Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.

Option availability in Ukraine

Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).

Option	UA registration	NSZU	Cost orientation	Access pathway
Standard plan Sacituzumab govitecan monotherapy (TNBC ≥2L; HR+/HER2- ≥3L) (REG-SACITUZUMAB) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Standard plan Olaparib monotherapy (BRCA-mutant HER2- breast: metastatic OR adjuvant high-risk early) (REG-OLAPARIB-BREAST)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan Olaparib monotherapy (BRCA-mutant HER2- breast: metastatic OR adjuvant high-risk early) (REG-OLAPARIB-BREAST)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan T-DXd monotherapy (HER2+ metastatic 2L+, also HER2-low metastatic) (REG-TDXD-METASTATIC)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT06790264 Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06716073 Long-Term Outcomes of Endoscopic-assisted vs Conventional Breast-conserving Surgery in Breast Cancer Patients After Neoadjuvant Therapy: a Randomized, Multicenter, Open Label, Non-inferiority Trial No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05861271 Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06807502 Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04790305 Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07003009 Immun Checkpoint Washout in Patients With Invasive Ductal Breast Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06823414 Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT03201861 Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07260188 Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02945579 Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-08-18.

plan_id: PLAN-BREAST-TNBC-2L-SACI-001-V1 | version: 1 | generated: 2026-08-18T07:59:48.659605+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.